The following data is part of a premarket notification filed by Pacific Andrology, Inc. with the FDA for Assisted Hatching Micropipettes, Denuding Pipettes, Holding Micropipettes, Icsi Micropipettes, Partial Zone Dissection M.
| Device ID | K991388 |
| 510k Number | K991388 |
| Device Name: | ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M |
| Classification | Microtools, Assisted Reproduction (pipettes) |
| Applicant | PACIFIC ANDROLOGY, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland PACIFIC ANDROLOGY, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MQH |
| CFR Regulation Number | 884.6130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-21 |
| Decision Date | 1999-09-13 |